2022
Comparative Safety and Effectiveness of Biologic Therapy for Crohn’s Disease: A CA-IBD Cohort Study
Singh S, Kim J, Luo J, Paul P, Rudrapatna V, Park S, Zheng K, Syal G, Ha C, Fleshner P, McGovern D, Sauk J, Limketkai B, Dulai P, Boland B, Eisenstein S, Ramamoorthy S, Melmed G, Mahadevan U, Sandborn W, Ohno-Machado L. Comparative Safety and Effectiveness of Biologic Therapy for Crohn’s Disease: A CA-IBD Cohort Study. Clinical Gastroenterology And Hepatology 2022, 21: 2359-2369.e5. PMID: 36343846, PMCID: PMC12145724, DOI: 10.1016/j.cgh.2022.10.029.Peer-Reviewed Original ResearchConceptsTNF-α antagonistsRisk of hospitalizationUstekinumab-treated patientsCrohn's diseaseSerious infectionsLower riskMulticenter cohortInflammatory bowel disease-related surgeryTumor necrosis factor α antagonistsNecrosis factor α antagonistsDisease-related surgeryHigher comorbidity burdenVedolizumab-treated patientsNew biologic agentsPropensity-score matchingComorbidity burdenCause hospitalizationAdult patientsBiologic therapyCohort studyPrior hospitalizationBiologic agentsΑ antagonistsBiologic classesComparative safetyVaccination Recommendations for Psoriasis and Atopic Dermatitis Patients on Biologic Therapy: A Practical Guide.
Fan R, Cohen JM. Vaccination Recommendations for Psoriasis and Atopic Dermatitis Patients on Biologic Therapy: A Practical Guide. The Yale Journal Of Biology And Medicine 2022, 95: 249-255. PMID: 35782480, PMCID: PMC9235258.Peer-Reviewed Original ResearchMeSH KeywordsBiological TherapyCOVID-19COVID-19 VaccinesDermatitis, AtopicHumansInterleukin InhibitorsPsoriasisVaccinationConceptsAtopic dermatitis patientsBiologic therapyVaccination recommendationsDermatitis patientsTreatment of psoriasisNovel biologic therapiesIL-17IL-23Atopic dermatitisIL-12/23Vaccine administrationClinical dataHealthcare providersAvailable guidelinesPsoriasisTherapyUnique considerationsPatientsPractical guideVaccinationDermatitisTNFαInfectionDermatologistsAdministrationEffectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study
Nguyen N, Luo J, Paul P, Kim J, Syal G, Ha C, Rudrapatna V, Park S, Parekh N, Zheng K, Sauk J, Limketkai B, Fleshner P, Eisenstein S, Ramamoorthy S, Melmed G, Dulai P, Boland B, Mahadevan U, Sandborn W, Ohno-Machado L, McGovern D, Singh S. Effectiveness and Safety of Biologic Therapy in Hispanic Vs Non-Hispanic Patients With Inflammatory Bowel Diseases: A CA-IBD Cohort Study. Clinical Gastroenterology And Hepatology 2022, 21: 173-181.e5. PMID: 35644340, PMCID: PMC9701245, DOI: 10.1016/j.cgh.2022.05.008.Peer-Reviewed Original ResearchConceptsInflammatory bowel diseaseNon-Hispanic patientsBiologic-treated patientsHispanic patientsSerious infectionsBiologic therapyBowel diseasePropensity score-matched cohortBurden of inflammationRisk of hospitalizationHigh ratePropensity-score matchingCause hospitalizationAdult patientsBiologic initiationCohort studyBiologic agentsMedication useHigh burdenHigh riskHospitalizationPatientsSurvival analysisSurgeryAbstractText
2021
No Benefit of Continuing 5-Aminosalicylates in Patients with Crohn’s Disease Treated with Anti-metabolite Therapy
Picetti D, Kim J, Zhu W, Sandborn W, Jairath V, Singh S. No Benefit of Continuing 5-Aminosalicylates in Patients with Crohn’s Disease Treated with Anti-metabolite Therapy. Digestive Diseases And Sciences 2021, 67: 3115-3123. PMID: 34797442, PMCID: PMC9117569, DOI: 10.1007/s10620-021-07301-x.Peer-Reviewed Original ResearchMeSH KeywordsAdrenal Cortex HormonesAnti-Inflammatory Agents, Non-SteroidalBiological TherapyCrohn DiseaseHumansMesalamineConceptsAnti-metabolite therapyCrohn's diseaseCox proportional hazards analysisCD-related hospitalizationCD-related surgeryAdministrative claims databaseProportional hazards analysisCorticosteroid useTreatment escalationClaims databaseClinical benefitResidual confoundingHigh riskPatientsDisease severityMonotherapyDiseaseKey covariatesTherapyHazard analysisOutcomesRiskEscalationMethodsPatientsHospitalization
2020
Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies
Strober B, Menter A, Leonardi C, Gordon K, Lambert J, Puig L, Photowala H, Longcore M, Zhan T, Foley P. Efficacy of risankizumab in patients with moderate‐to‐severe plaque psoriasis by baseline demographics, disease characteristics and prior biologic therapy: an integrated analysis of the phase III UltIMMa‐1 and UltIMMa‐2 studies. Journal Of The European Academy Of Dermatology And Venereology 2020, 34: 2830-2838. PMID: 32320088, PMCID: PMC7818271, DOI: 10.1111/jdv.16521.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalBiological TherapyDemographyDouble-Blind MethodHumansPsoriasisSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsPrior biologic exposureSevere plaque psoriasisBaseline patient demographicsEfficacy of risankizumabPhase 3 trialDisease characteristicsWeek 16Logistic regression analysisPlaque psoriasisPatient demographicsBiologic exposureSuperior efficacyPlacebo-controlled phase 3 trialHumanized IgG monoclonal antibodyPrior biologic therapyProportion of patientsBody mass indexRegression analysisBaseline characteristicsBaseline demographicsBiologic therapyPsoriasis AreaWeek 52Patient characteristicsIgG monoclonal antibodiesNo benefit of continuing vs stopping 5‐aminosalicylates in patients with ulcerative colitis escalated to anti‐metabolite therapy
Singh S, Kim J, Zhu W, Dulai P, Sandborn W, Jairath V. No benefit of continuing vs stopping 5‐aminosalicylates in patients with ulcerative colitis escalated to anti‐metabolite therapy. Alimentary Pharmacology & Therapeutics 2020, 52: 481-491. PMID: 32573825, PMCID: PMC8015755, DOI: 10.1111/apt.15876.Peer-Reviewed Original ResearchConceptsAnti-metabolite therapyUlcerative colitisCorticosteroid useRisk of UCCox proportional hazards analysisAdministrative claims databaseEmergency department visitsProportional hazards analysisComorbidity burdenTreatment escalationBiologic therapyAbdominal surgeryDepartment visitsClinical benefitClaims databaseResidual confoundingHigh riskPatientsDisease severityMonotherapyTherapyHospitalisationColitisSurgeryMonthsCharacterization of insufficient responders to ustekinumab in patients with moderate-to-severe psoriasis in the US Corrona Psoriasis Registry
Van Voorhees A, Mason M, Harrold L, Guo N, Guana A, Tian H, Herrera V, Strober B. Characterization of insufficient responders to ustekinumab in patients with moderate-to-severe psoriasis in the US Corrona Psoriasis Registry. Journal Of Dermatological Treatment 2020, 32: 907-915. PMID: 32027197, DOI: 10.1080/09546634.2020.1720586.Peer-Reviewed Original ResearchMeSH KeywordsBiological TherapyHumansPsoriasisRegistriesSeverity of Illness IndexTreatment OutcomeUstekinumabConceptsCorrona Psoriasis RegistrySevere psoriasisPsoriasis RegistryInsufficient respondersPsoriasis body surface areaBody surface areaLogistic regression modelingReal-world studyBiologic therapyPatient demographicsUS patientsBiologic treatmentDisease characteristicsInadequate responseInsufficient responsePatientsPsoriasisDecreased likelihoodRespondersRegistryVisitsRegression modelingEnrollmentFollowOutcomes
2019
Association of Biologic Therapy With Coronary Inflammation in Patients With Psoriasis as Assessed by Perivascular Fat Attenuation Index
Elnabawi YA, Oikonomou EK, Dey AK, Mancio J, Rodante JA, Aksentijevich M, Choi H, Keel A, Erb-Alvarez J, Teague HL, Joshi AA, Playford MP, Lockshin B, Choi AD, Gelfand JM, Chen MY, Bluemke DA, Shirodaria C, Antoniades C, Mehta NN. Association of Biologic Therapy With Coronary Inflammation in Patients With Psoriasis as Assessed by Perivascular Fat Attenuation Index. JAMA Cardiology 2019, 4: 885-891. PMID: 31365032, PMCID: PMC6669789, DOI: 10.1001/jamacardio.2019.2589.Peer-Reviewed Original ResearchConceptsPerivascular fat attenuation indexFat attenuation indexBiologic psoriasis therapyBiologic therapyCoronary inflammationSevere psoriasisPsoriasis therapyCoronary plaquesSkin diseasesAnti-tumor necrosis factor αChronic inflammatory skin diseaseDifferent biologic agentsTraditional risk scoresCoronary plaque burdenLow cardiovascular riskProspective cohort studyAnti-inflammatory effectsCoronary artery diseaseInflammatory skin diseaseCoronary atherosclerotic plaquesNecrosis factor αSevere skin diseaseCardiovascular eventsCardiovascular riskCohort study
2018
A combinatorial approach for robust transgene delivery and targeted expression in mammary gland for generating biotherapeutics in milk, bypassing germline gene integration
Ganguli N, Ganguli N, Chandra S, Choubey M, Sarkar D, Majumdar S. A combinatorial approach for robust transgene delivery and targeted expression in mammary gland for generating biotherapeutics in milk, bypassing germline gene integration. Applied Microbiology And Biotechnology 2018, 102: 6221-6234. PMID: 29855689, DOI: 10.1007/s00253-018-9094-2.Peer-Reviewed Original ResearchConceptsΒ-casein promoterGene integrationHemagglutinin-neuraminidaseEpithelial cell-specific expressionSpecific gene expressionCell-specific expressionMammary epithelial cellsEpithelial cellsNative genomeAnimal bioreactorsMammary glandMembrane fusionGene expressionSpecific expressionTransgene constructLuminal epithelial cellsMilk glandTargeted expressionViral membraneTransgeneFarmed animalsProtein expressionTherapeutic proteinsPromoterFusion factorOutcomes of Treatment for Latent Tuberculosis Infection in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy
Ramos GP, Stroh G, Al-Bawardy B, Faubion WA, Papadakis KA, Escalante P. Outcomes of Treatment for Latent Tuberculosis Infection in Patients With Inflammatory Bowel Disease Receiving Biologic Therapy. Inflammatory Bowel Diseases 2018, 24: 2272-2277. PMID: 29718223, DOI: 10.1093/ibd/izy133.Peer-Reviewed Original ResearchMeSH KeywordsAdultAntitubercular AgentsBiological TherapyColitis, UlcerativeCrohn DiseaseFemaleFollow-Up StudiesGastrointestinal AgentsHumansInterferon-gamma Release TestsLatent TuberculosisMaleMycobacterium tuberculosisPrognosisProspective StudiesRetrospective StudiesTreatment OutcomeTuberculin TestConceptsLatent tuberculosis infectionInflammatory bowel diseaseTuberculin skin testBiologic therapyLTBI treatmentIBD patientsTuberculosis reactivationBowel diseaseTuberculosis infectionLTBI treatment regimenReactivation of TBRisk of reactivationInterferon-gamma releaseOutcome of treatmentStudy inclusion criteriaMedian annual riskAdalimumab monotherapyIsoniazid therapyTB reactivationCertolizumab pegolPrimary outcomeRetrospective reviewTreatment regimenMedian timeGamma release
2017
Incidence of and Predictors for Early Discontinuation of Biological Therapies in Veteran Patients with Inflammatory Bowel Disease
Feagins LA, Waljee A, Hou JK, Gu P, Kanjo S, Rudrapatna V, Cipher DJ, Govani S, Gaidos J. Incidence of and Predictors for Early Discontinuation of Biological Therapies in Veteran Patients with Inflammatory Bowel Disease. Inflammatory Bowel Diseases 2017, 23: 1434-1439. PMID: 28570429, DOI: 10.1097/mib.0000000000001145.Peer-Reviewed Original ResearchConceptsInflammatory bowel diseaseBiological therapyAdverse drug reactionsConcomitant thiopurinesPrimary nonresponseEarly discontinuationBowel diseaseDrug reactionsDiagnosis of IBDBiological agentsFirst biological agentRetrospective cohort studyInitiation of therapyCourse of therapyVA hospital systemIleocolonic diseaseVA cohortCohort studyVeteran patientsMedical recordsRisk factorsCommon reasonPatientsDiscontinuationTherapy
2016
Emerging biological therapies for the treatment of myelodysplastic syndromes
Zeidan AM, Stahl M, Komrokji R. Emerging biological therapies for the treatment of myelodysplastic syndromes. Expert Opinion On Emerging Drugs 2016, 21: 283-300. PMID: 27486848, DOI: 10.1080/14728214.2016.1220534.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAnimalsBiological TherapyDrug DesignEpigenesis, GeneticHumansMolecular Targeted TherapyMyelodysplastic SyndromesPrognosisRNA SplicingConceptsMyelodysplastic syndromeHistone deacetylase inhibitorsTreatment optionsNovel agentsLower-risk myelodysplastic syndromesHigh-risk myelodysplastic syndromeHMA treatment failureRisk-adaptive therapySignificant clinical activityNovel treatment optionsNovel effective therapiesNovel therapeutic approachesHMA failureBiological therapyTreatment failureBone marrow nicheClinical trialsEffective therapyClinical activityImmune responseTherapeutic approachesSurvival advantageFuture therapiesImmune systemDeacetylase inhibitors
2015
Skin Signs of Rheumatoid Arthritis and its Therapy-Induced Cutaneous Side Effects
Xue Y, Cohen JM, Wright NA, Merola JF. Skin Signs of Rheumatoid Arthritis and its Therapy-Induced Cutaneous Side Effects. American Journal Of Clinical Dermatology 2015, 17: 147-162. PMID: 26649439, DOI: 10.1007/s40257-015-0167-z.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, CutaneousAntirheumatic AgentsArthritis, RheumatoidBiological TherapyDermatomyositisDrug EruptionsHumansLichenoid EruptionsLupus Erythematosus, CutaneousMelanomaPyoderma GangrenosumRheumatoid NoduleRheumatoid VasculitisSkin DiseasesSkin NeoplasmsSweet SyndromeTumor Necrosis Factor-alphaConceptsRheumatoid arthritisAdverse effectsBiologic disease-modifying agentsManagement of RAAnti-TNFα agentsRA disease activityCutaneous adverse effectsSystemic inflammatory disorderCutaneous side effectsDisease-modifying agentsGranulomatous skin disorderConnective tissue disordersNeutrophilic dermatosisRheumatoid vasculitisDisease activityAggressive treatmentRheumatoid nodulesCutaneous findingsClinical presentationTherapeutic challengeGranulomatous conditionsInflammatory disordersSkin signsCutaneous diseaseCutaneous effectsInterleukin‐23 inhibition for the treatment of psoriasis: the next frontier for high‐efficacy biologic therapy
Strober B. Interleukin‐23 inhibition for the treatment of psoriasis: the next frontier for high‐efficacy biologic therapy. British Journal Of Dermatology 2015, 173: 887-888. PMID: 26511822, DOI: 10.1111/bjd.14095.Peer-Reviewed Original ResearchUpdate on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook
Kelly CR, Kahn S, Kashyap P, Laine L, Rubin D, Atreja A, Moore T, Wu G. Update on Fecal Microbiota Transplantation 2015: Indications, Methodologies, Mechanisms, and Outlook. Gastroenterology 2015, 149: 223-237. PMID: 25982290, PMCID: PMC4755303, DOI: 10.1053/j.gastro.2015.05.008.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsMeSH KeywordsAdultBiological TherapyClostridioides difficileClostridium InfectionsFecesFemaleHumansMaleMicrobiotaMiddle AgedConceptsFecal microbiota transplantationClostridium difficile infectionGut microbiotaRecurrent Clostridium difficile infectionInflammatory bowel diseaseIrritable bowel syndromeTreatment of patientsRobust safety dataLong-term safetyBowel diseaseBowel syndromeMetabolic syndromeMicrobiota transplantationDifficile infectionSafety dataTherapeutic efficacyOrgan systemsDisease statesHuman gutSyndromePossible roleDiseaseEfficacyMicrobiotaTreatment
2013
What Is the Value of a Food and Drug Administration Investigational New Drug Application for Fecal Microbiota Transplantation to Treat Clostridium difficile Infection?
Hecht GA, Blaser MJ, Gordon J, Kaplan LM, Knight R, Laine L, Peek R, Sanders ME, Sartor B, Wu GD, Yang VW. What Is the Value of a Food and Drug Administration Investigational New Drug Application for Fecal Microbiota Transplantation to Treat Clostridium difficile Infection? Clinical Gastroenterology And Hepatology 2013, 12: 289-291. PMID: 24148361, DOI: 10.1016/j.cgh.2013.10.009.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus Statements
2012
Glycolipid Antigens for Treating Hepatic Colorectal Cancer Metastases and Their Effect on the Therapeutic Efficacy of Live Attenuated Listeria monocytogenes
Olino K, Edil BH, Meckel KF, Pan X, Thuluvath A, Pardoll DM, Schulick RD, Yoshimura K, Weber WP. Glycolipid Antigens for Treating Hepatic Colorectal Cancer Metastases and Their Effect on the Therapeutic Efficacy of Live Attenuated Listeria monocytogenes. JAMA Surgery 2012, 147: 480-482. PMID: 22785644, PMCID: PMC4144826, DOI: 10.1001/archsurg.2011.2206.Peer-Reviewed Original ResearchConceptsNatural killer T cellsHepatic colorectal cancer metastasesKiller T cellsColorectal cancer metastasisT cellsNatural Killer T Cell SubsetsCancer metastasisAntitumor activityT cell subsetsAttenuated Listeria monocytogenesPotential of glycolipidsTumor challengeHepatic metastasesMultiple administrationsGlycolipid antigensTherapeutic efficacyListeria monocytogenesActin AAntitumor efficacyMetastasisFurther investigationAdministrationEfficacySpecific glycolipidsSurvival
2009
Chemotherapy and biologic therapies for melanoma: do they work?
Jilaveanu LB, Aziz SA, Kluger HM. Chemotherapy and biologic therapies for melanoma: do they work? Clinics In Dermatology 2009, 27: 614-625. PMID: 19880049, DOI: 10.1016/j.clindermatol.2008.09.020.Peer-Reviewed Original ResearchConceptsResponse rateMinority of patientsSubset of patientsInterleukin-2 (IL-2) resultsImproved response ratesIncidence of melanomaIdentification of predictorsCombination of agentsUnresectable diseaseBiologic therapyOlder regimensOverall survivalStandard chemotherapyTherapeutic optionsClinical trialsNew agentsSmall molecule inhibitorsSingle agentImmune systemMonoclonal antibodiesDeath rateMelanomaMalignant melanocytesChemotherapyMolecule inhibitors
2007
The use of therapeutic interchange for biologic therapies.
Flood J, Mihalik C, Fleming R, Strober B, Zucker D, Burgoyne D. The use of therapeutic interchange for biologic therapies. Managed Care 2007, 16: 51-62. PMID: 17285813.Peer-Reviewed Original ResearchMeSH KeywordsBiological TherapyChronic DiseaseDisease ManagementHumansPharmaceutical ServicesTherapeutic EquivalencyUnited StatesConceptsSelective serotonin reuptake inhibitorsProton pump inhibitorsBiologic agentsTherapeutic interchangeRheumatoid arthritisBiologic therapyHMG-CoA reductase inhibitorsSerotonin reuptake inhibitorsPopulation-based outcomesHealth care professionalsMode of administrationOverall treatment costsTolerability profileAppropriate therapyReuptake inhibitorsPsoriasis therapyPump inhibitorsDrug classesIndividual patientsCare professionalsNew agentsEnzyme inhibitorsPatientsReductase inhibitorsTherapy
2002
The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma
Herbst RS, Khuri FR, Lu C, Liu DD, Fossella FV, Glisson BS, Pisters KM, Shin DM, Papadimitrakopoulou VA, Kurie JM, Blumenschein G, Kies MS, Zinner R, Jung MS, Lu R, Lee JJ, Munden RF, Hong WK, Lee JS. The novel and effective nonplatinum, nontaxane combination of gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma. Cancer 2002, 95: 340-353. PMID: 12124835, DOI: 10.1002/cncr.10629.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAntimetabolites, AntineoplasticAntineoplastic Agents, PhytogenicAntineoplastic Combined Chemotherapy ProtocolsBiological TherapyCarcinoma, Non-Small-Cell LungCombined Modality TherapyDeoxycytidineDisease ProgressionFemaleGemcitabineHumansLung NeoplasmsMaleMiddle AgedSurvival RateVinblastineVinorelbineConceptsNonsmall cell lung carcinomaYear survival rateAdvanced nonsmall cell lung carcinomaThird-line therapyPhase II trialMedian survival timeCell lung carcinomaGrade 3Survival rateSignificant myelosuppressionStable diseaseII trialLung carcinomaSurvival timeStage IV nonsmall cell lung carcinomaDay 1Day 15Formal phase II trialCurrent phase II trialDose of vinorelbineGemcitabine/vinorelbineGrade 3 granulocytopeniaMedian performance statusMinimal grade 3Prior chemotherapy regimens
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